Michael Barbella, Managing Editor03.18.22
Abiomed is touting early, positive clinical data from its preCARDIA system study.
The VENUS-HF Early Feasibility Study enrolled 30 patients with acutely decompensated heart failure (ADHF) who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days. The multicenter, prospective, single-armstudy found:
“The study met the safety and feasibility endpoints and suggest for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF,” said Navin Kapur, M.D., the study’s lead author and executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center.
The preCARDIA system is designed to improve decongestion in ADHF patients by intermittently occluding the superior vena cava. Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. Diuretics may help to improve heart failure symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with chronic heart failure. preCARDIA is designed to reduce filling pressure as blood enters the heart and lungs, which may enable the heart and kidneys to work more effectively, potentially providing therapy for patients non-responsive to diuretics, estimated to be approximately 300,000 of the 1 million U.S. ADHF admissions annually.
The trial results support additional study of preCARDIA. In November 2021, the U.S. Food and Drug Administration authorized preCARDIA’s early feasibility study to be expanded by 30 additional patients to a total of 60 patients.
preCARDIA is an investigational device, limited by federal law to investigational use only.
Based in Danvers, Mass., Abiomed Inc. develops medical devices that provide circulatory support and oxygenation. Its products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure.
The VENUS-HF Early Feasibility Study enrolled 30 patients with acutely decompensated heart failure (ADHF) who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days. The multicenter, prospective, single-armstudy found:
- Freedom from device- or procedure-related major adverse events in all patients (n=30/30)
- Successful placement, activation and removal of preCARDIA in 97 percent of patients (n=29/30)
- Right atrial pressure decreased 34 percent from baseline (p<0.001)
- Pulmonary capillary wedge pressure decreased 27 percent from baseline (p<0.001)
- Urine output increased by 130 percent from pretreatment values (p<0.01)
- Net fluid output increased by 156 percent from pretreatment values (p<0.01)
“The study met the safety and feasibility endpoints and suggest for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF,” said Navin Kapur, M.D., the study’s lead author and executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center.
The preCARDIA system is designed to improve decongestion in ADHF patients by intermittently occluding the superior vena cava. Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. Diuretics may help to improve heart failure symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with chronic heart failure. preCARDIA is designed to reduce filling pressure as blood enters the heart and lungs, which may enable the heart and kidneys to work more effectively, potentially providing therapy for patients non-responsive to diuretics, estimated to be approximately 300,000 of the 1 million U.S. ADHF admissions annually.
The trial results support additional study of preCARDIA. In November 2021, the U.S. Food and Drug Administration authorized preCARDIA’s early feasibility study to be expanded by 30 additional patients to a total of 60 patients.
preCARDIA is an investigational device, limited by federal law to investigational use only.
Based in Danvers, Mass., Abiomed Inc. develops medical devices that provide circulatory support and oxygenation. Its products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure.